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Novasep and Exelixis have signed a manufacturing services agreement for the CGMP clinical manufacturing of a next-generation ADC candidate.
Novasep, supplier of services and technologies for the life sciences industry, and Exelixis, an oncology-focused biotechnology company, have signed a manufacturing services agreement for the current good manufacturing practice (CGMP) clinical manufacturing of a next-generation antibody-drug conjugate (ADC) candidate.
According to a July 6, 2021 press release, the agreement will cover the CGMP manufacture of Exelixis’ XB002, a novel tissue factor-targeting ADC for oncology applications. The investigational new drug filing of XB002 was accepted by FDA in April 2021, and a Phase I clinical trial of the drug in patients with advanced solid tumors was started in the second quarter of the year. The ADC is already being manufactured at Novasep’s site in Le Mans, France, for the clinical trial.
“As the first ADC in our growing biologics pipeline to enter clinical development, XB002 is an important program for Exelixis,” said Khalid Shah, senior vice-president, Pharmaceutical Operations and Supply Chain, Exelixis, in the press release. “Novasep’s ADC process development and manufacturing capabilities were integral to our ability to initiate XB002’s first Phase I study on an aggressive timeline this spring. We look forward to leveraging Novasep’s highly specialized ADC expertise as work on the XB002 clinical development program continues.”
“The ADC clinical pipeline continues to strengthen thanks to innovators such as Exelixis. These therapies have the potential to serve as new treatment options for patients around the world and our aim is to accompany their development,” added Michel Spagnol, chairman and CEO of Novasep, in the press release. “We are proud to support Exelixis with our manufacturing services.”